What is NDC 72189-580?

72189-580 is the product NDC for Buprenorphine Sublingual C-III, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Buprenorphine Sublingual C-III?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buprenorphine Sublingual C-III NDC 72189-580

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0580Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
72189-580-60	7218905806072189058060	60 TABLET in 1 BOTTLE (72189-580-60)Marketed from Sep 16, 2024
72189-580-90	7218905809072189058090	90 TABLET in 1 BOTTLE (72189-580-90)Marketed from Sep 16, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Buprenorphine Sublingual C-III
Generic name (nonproprietary): buprenorphine sublingual c-iii
Active ingredients: Buprenorphine hydrochloride — 2 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078633
Marketing start: Sep 16, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 72189-580_2498906f-8f6e-1024-e063-6394a90a6b47SPL ID 2498906f-8f6e-1024-e063-6394a90a6b47SPL set ID 22412030-a641-28d8-e063-6294a90a2fefRxCUI 351264UNII 56W8MW3EN1
Pharmacologic class: Partial Opioid Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472189058060 followed by a unit qualifier and the quantity

Package 72189-0580-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 16, 2024.

Indications (excerpt from the label)

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-580

What is NDC 72189-580?: 72189-580 is the product NDC for Buprenorphine Sublingual C-III, Buprenorphine hydrochloride 2 mg/1 tablet, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Buprenorphine Sublingual C-III.
What is the active ingredient?: Buprenorphine hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Buprenorphine Sublingual C-III?: 1 other product NDC are listed under this name. See all Buprenorphine Sublingual C-III NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Buprenorphine Sublingual C-III NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buprenorphine Sublingual C-III	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Direct_Rx	72189-582	72189-0582-60

Other NDCs under ANDA 078633

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078633
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Hikma Pharmaceuticals USA Inc.	0054-0177
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Bryant Ranch Prepack	71335-1163
Buprenorphine Sublingual C-III	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Direct_Rx	72189-582
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2014
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Redpharm Drug	67296-2123
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	REMEDYREPACK INC.	70518-2226
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Major Pharmaceuticals	0904-7154
Buprenorphine	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Hikma Pharmaceuticals USA Inc.	0054-0176
Buprenorphine	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Major Pharmaceuticals	0904-7155
Buprenorphine HCl	Buprenorphine hydrochloride 2 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0176
Buprenorphine HCl	Buprenorphine hydrochloride 8 mg/1	TabletSublingual	Clinical Solutions Wholesale, LLC	58118-0177